{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"FDA Oversight of PET Drug Products--Questions and Answers.\" This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2012/12/04/2012-29157.html","cfr_references":[],"citation":"77 FR 71803","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0080"],"dockets":[],"document_number":"2012-29157","effective_on":null,"end_page":71804,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/12/04/2012-29157.xml","html_url":"https://www.federalregister.gov/documents/2012/12/04/2012-29157/guidance-on-food-and-drug-administration-oversight-of-positron-emission-tomography-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-29157?publication_date=2012-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-12-04/2012-29157/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":90,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-12-04/pdf/2012-29157.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-29157.pdf?1354542910","publication_date":"2012-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/12/04/2012-29157.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0080","supporting_documents_count":0,"docket_id":"FDA-2012-D-0080","regulation_id_number":null,"title":"FDA Regulation of PET Drug Products - Questions and Answers; Draft Guidance","checked_regulationsdotgov_at":"2012-12-24T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71803,"subtype":null,"title":"Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability","toc_doc":"Guidance on Oversight of Positron Emission Tomography Drug Products  Questions and Answers","toc_subject":null,"topics":[],"type":"Notice","volume":77}